Quality Assurance Operations Specialist

**Description**

Quality Operations Specialist is responsible for quality assurance activities related, but not limited to, incoming raw materials & components, manufacturing floor operations (compounding, filling, utilities and warehouse), and suppliers.

Quality assurance activities include leading deviation handling, root cause analysis and CAPA development, conducting document reviews to verify effectiveness of procedures and instructions, and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis.

Issues Resolution/Continuous Improvement

⁃ Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff and suppliers to address product quality issues and GMP related activities

⁃ Certify CAPA completion and effectiveness

⁃ Escalate critical issues to Quality/Operations leadership as required

⁃ Investigate critical customer and co...